FDA Identifies Review Issues For Spero's Tebipenem Application, Shares Plunge
Spero Therapeutics Inc (NASDAQ: SPRO) will defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the FDA.
The discussion suggested that the data package may be insufficient to support approval during this review cycle.
In evaluating the efficacy of tebipenem HBr in Phase 3 (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population.
Also Read: FDA Lifts Clinical Hold On Spero Therapeutics' Lung Infection Program.
The effect of this new analysis was to reduce the number of evaluable patients in the primary analysis population compared with those resulting from the trial's pre-specified micro-ITT population as outlined in the statistical analysis plan.
Hence, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met.
With this development, Spero will reduce its workforce by approximately 75% to 35 from 146 full-time employees.
The company will incur approximately $8.0 million in severance costs.
Spero would prioritize advancing SPR720 and SPR206 to Phase 2 milestones, including key deliverables through 2024, while engaging with the FDA on the appropriate path forward for tebipenem HBr.
Spero ended 2021 with an estimated $146.4 million in cash. Based on the anticipated cost savings, the company anticipates a cash runway into late 2023.
Price Action: SPRO shares are down 61.30% at $1.97 on the last check Tuesday.
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